Temozolomide for Relapsed Sensitive or Refractory Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:

Phase II Study of Temozolomide for Relapsed Sensitive or Refractory Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00740636
• Other study ID #: 08-065
• Status: Completed
• Phase: Phase 2
• First received: August 22, 2008
• Last updated: December 29, 2015
• Start date: August 2008
• Est. completion date: February 2013

Study information

• Verified date: December 2015
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether treatment with temozolomide will shrink small cell lung cancer tumors. Temozolomide is an oral chemotherapy drug that is currently used to treat brain cancer and melanoma.

As part of this study, we will be doing additional tests that may help us understand how temozolomide works. First, if there is a tumor sample from a biopsy done in the past, it will be analyzed for an abnormal gene that may be present in lung cancer. Before starting temozolomide, a research blood test will be done to look for the same abnormal gene we are looking for in your tumor sample. Also, before starting temozolomide and every time you have a repeat CT scan, a research blood test will be done to analyze the number of tumor cells in your bloodstream.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must have pathologically confirmed SCLC at MSKCC that has progressed after one or two chemotherapy regimens.

• At least 3 weeks must have elapsed since last chemotherapy or radiation treatment and initiation of study treatment.

• Karnofsky performance status > or = to 60%.

• Patients must have measurable disease, this can include brain metastases.

• Patients must have normal organ and marrow function as defined below:

• - leukocytes > 3,000/mcL

• platelets > 100,000/mcL

• total bilirubin < 1.5 mg/dL

• AST(SGOT)/ALT(SGPT) < 2.5 X institutional upper limit of normal

• Creatinine < 2.0 mg/dl

• For women of child-bearing potential, negative pregnancy test within 7 days prior to starting temozolomide.

• Men and women of childbearing potential must agree to practice adequate contraception.

• Ability to understand and the willingness to sign a written informed consent document.

• Both men and women of all races and ethnic groups are eligible for this trial.

Exclusion Criteria:

• Patients who have not recovered from adverse events of previous therapies.

• Patients receiving other investigational agents.

• Patients with leptomeningeal involvement.

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.

• Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition or HIV-positive patients on combination antiretroviral therapy. However, HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because these patients are at increased risk of lethal infections when treated with marrow- suppressive therapy. Excluding patients on HAART is necessary due to the potential for pharmacokinetic interactions with temozolomide.

• Women who are pregnant or breast feeding, due to possible adverse effects on the developing fetus or infant due to study drug.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• Temozolomide
Temozolomide will be administered orally once per day on days 1 through 5 of a 28 day cycle. The dose will be 200mg/m2/day.
• Temozolomide
Temozolomide will be administered orally once per day on days 1 through 5 of a 28 day cycle. The dose will be 200mg/m2/day.

Locations

Country	Name	City	State
United States	Memoral Sloan Kettering Cancer Center	Basking Ridge	New Jersey
United States	Memorial Sloan-Kettering Cancer Center at Commack	Commack	New York
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Memorial Sloan-Kettering Cancer Center at Mercy Medical Center	Rockville Centre	New York
United States	Memoral Sloan Kettering Cancer Center@Phelps	Sleepy Hollow	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Schering-Plough

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Objective Overall Response	The objective response is defined as all complete responses and partial responses based on the modified RECIST.Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.	2 years	No

External Links

•   Memorial Sloan-Kettering Cancer Center